TAILORx trial finds 99% of women with low Oncotype DX® Recurrence Score® are free of breast cancer recurrence after five years of hormone therapy alone

New England Journal of Medicine publishes positive results from one of the largest-ever adjuvant breast cancer trials

TORONTO, Sept. 28, 2015 /CNW/ - Genomic Health today announced the presentation of the first results^[i] from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, a large, multicentre, prospectively conducted trial, including Canadian patients, sponsored by the U.S. National Cancer Institute (NCI). The study demonstrated that a group of early-stage breast cancer patients with low Oncotype DX Recurrence Score results of 10 or less who received hormonal therapy alone without chemotherapy had less than a one percent chance of distant recurrence at five years.

Presented at the 2015 European Cancer Congress (ECC2015), results from a group of 1,626 patients with a Recurrence Score result between 0 and 10 demonstrated that 99.3 percent of node-negative, estrogen receptor-positive, HER2-negative patients who met accepted guidelines for recommending chemotherapy in addition to hormonal therapy had no distant recurrence at five years after treatment with hormonal therapy alone. Outcomes were excellent irrespective of patient age, tumour size, and tumour grade. 

"TAILORx is a unique, large breast cancer trial that provides us with information no other trial to date has offered," said Kathleen Pritchard, MD, senior scientist, Sunnybrook Health Sciences Centre in Toronto.  "The results of this trial highlight the clinical utility of Oncotype DX and provide physicians and patients with greater confidence in using this test to make chemotherapy treatment decisions."

The trial enrolled 10,273 patients across 1,182 sites and major cancer centres in six countries, including Canada.  TAILORx used the Oncotype DX test on every patient to quantify individual risk of recurrence in order to assign the appropriate treatment. This study is evaluating the effect of chemotherapy only for those with a mid-range Recurrence Score result, as previous Oncotype DX studies have already confirmed the benefit of adjuvant chemotherapy for those in the high Recurrence Score range and minimal, if any, benefit for those in the low Recurrence Score range. The data safety monitoring board of the trial, as mandated by the study protocol, will continue to monitor outcomes in patients with a Recurrence Score result of 11 to 25 randomized to chemo-endocrine therapy or endocrine therapy alone.

"To date, more than 170,000 breast cancer patients have changed their treatment decision based the Oncotype DX test.  Many of these women who received high Oncotype DX scores were able to choose chemotherapy as a potentially life-saving treatment, while the majority were able to effectively pursue hormonal therapy alone and avoid the unnecessary side-effects of chemotherapy," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The rigorous TAILORx trial led by ECOG-ACRIN provides level 1A evidence supporting Oncotype DX as the only multigene expression assay that can identify the tens of thousands of patients each year who can effectively forego chemotherapy."

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payers. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's quarterly report on Form 10-Q for the year ended June 30, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

SOURCE Genomic Health, Inc.

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